Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention
NCT06686108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2025-05-07
Summary
This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.
Conditions
- T-cell Acute Lymphoblastic Leukemia
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- Relapse
Interventions
- DRUG
-
Azacitidine (AZA) Days 1 - 5
Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle
- DRUG
-
Decitabine (DAC)
decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.
- DRUG
-
venetoclax, 400mg/d, days 1-7 of each 28-day cycle
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-30
- Primary Completion
- 2027-10-30
- Completion
- 2028-10-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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